Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

FDA Places Idenix Pharma's IDX19368 On Clinical Hold

8/27/2012 11:24 AM ET

Idenix Pharmaceuticals Inc. (IDIX: Quote) announced that it received verbal notice from the U.S. Food and Drug Administration or FDA that a clinical hold has been placed on IDX19368, the Company's next-generation nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus or HCV infection.

Idenix said that the news follows an announcement that it made on August 16, 2012 related to a partial clinical hold placed on IDX184, the company's lead nucleotide polymerase inhibitor also under development for the treatment of HCV.

The FDA verbally informed Idenix that it placed IDX19368 on clinical hold due to concerns related to the serious cardiac-related adverse events reported for HCV patients treated with BMS-986094, a nucleotide polymerase inhibitor previously under development by Bristol-Myers Squibb Company. To date, no patients have been exposed to IDX19368.

As part of the partial clinical hold placed on IDX184, the FDA has requested additional cardiac testing of patients in the ongoing phase IIb clinical trial of IDX184. More than 50 patients have been scheduled for echocardiograms, and the Company is on track to submit these data to the FDA in the coming weeks.

To date, echocardiograms have been performed on a small number of these patients, and the results are normal.

Idenix said that its primary concern is patient safety and it will work diligently to expedite this review process and continue its discussions with the FDA with the goal of further advancing its drug candidates, IDX184 and IDX19368, in clinical development.

Register
To receive FREE breaking news email alerts for Idenix Pharmaceuticals Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Chipmaker Advanced Micro Devices Inc. said Thursday after the markets closed that its first quarter loss narrowed from last year, helped by strong revenue growth in its graphics and visual solutions business. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly revenue. After trending higher over the past few sessions, stocks showed a lack of direction throughout the trading day on Thursday. The major averages spent the session bouncing back and forth across the unchanged line before ending the day mixed. While the major averages closed on opposite sides of the unchanged line, they all showed only modest moves. U.S. Secretary Of State John Kerry said Thursday that he and his counterparts from Russia, Ukraine and the European Union have reached an agreement on a preliminary plan for ending the ongoing crisis in Ukraine. Kerry was speaking at the end of the Ukraine contact group's first meeting, comprising the foreign ministers of Russia, Ukraine, the EU and the U.S., in the Swiss city of Geneva.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.